Results Highlight Sapacitabine's Activity in MDS and Potential
Role as Second-Line Therapy After Treatment Failure of
Hypomethylating Agents

BERKELEY HEIGHTS, N.J., June 1, 2012 (GLOBE NEWSWIRE) --
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
(Cyclacel or the Company), today announced new data from an
ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine
capsules, the Company's lead product candidate, in older patients
with myelodysplastic syndromes
(MDS) after treatment failure of front-line hypomethylating agents,
such as azacitidine (Vidaza(R)) and/or decitabine (Dacogen(R)).
Median overall survival to date for all patients is 252 days or
approximately 8.4 months. Data were presented as a poster during
the 2012 American Society of Clinical Oncology (ASCO) Annual
Meeting being held June 1-5, 2012, in Chicago, Illinois.

"MDS patients have a poor outcome after treatment failures with
front-line therapies and the interim data reported at ASCO
indicates that sapacitabine is active in this patient population,"
said Hagop Kantarjian, M.D., Chairman & Professor, Department
of Leukemia, The University of Texas MD Anderson Cancer Center and
principal investigator for the study. "Median survival for patients
with
intermediate-2 or high-risk MDS following treatment failures of
hypomethylating agents is 4.3 to 5.6 months.1, 2 Effective
therapies are urgently needed for these patients."

Study Design

The open-label, multi-center, Phase 2 study randomized 63
patients aged 60 years or older with MDS of intermediate-2 (n=52)
or high-risk (n=11) classification by the International Prognostic
Scoring System (IPSS) at study entry to receive sapacitabine every
4 weeks on one of the 3 dosing schedules: 200 mg twice daily for 7
days (Arm G), 300 mg once daily for 7 days (Arm H), or 100 mg once
daily for 5 days per week for2 weeks (Arm I). The primary efficacy
endpoint of the study is 1-year survival with the objective of
identifying a dosing schedule that produces a better 1-year
survival rate in the event that all three dosing schedules are
active. All patients in the study progressed after receiving
azacitidine, decitabine, or both agents.

Results

At ASCO, the median overall survival for each arm was reported
as
follows: 240 days (approx. 8 months) for Arm G, 290 days (approx.
10
months) for Arm H, and 153 days (approx. 5 months) for Arm I. The
median overall survival for all three arms is 252 days (approx. 8
months). Complete remissions (CRs) and major hematologic
improvement (HI) in platelet counts or neutrophils, secondary
efficacy endpoints in the study, were observed on all 3 dosing
schedules as follows: 1 CR and
3 HI's in Arm G, 1 CR and 2 HI's in Arm H, and 2 CRs and 1 HI in
Arm I. The thirty-day mortality from all causes is 5%. Forty-one
percent of all patients received 4 or more cycles. More than 34% of
the patients are still alive and longer follow-up is needed to
assess 1-year survival and overall survival.

"As we continue patient enrollment in SEAMLESS, our pivotal
Phase 3 study of sapacitabine in elderly patients with acute
myeloid leukemia (AML), we are encouraged by the interim results of
sapacitabine as a second line treatment of older patients with
MDS," said Judy H. Chiao, M.D., Cyclacel's Vice President, Clinical
Development and Regulatory Affairs. "Sapacitabine may emerge as the
first oral drug that could address the unmet medical need in both
AML and MDS patients."

MDS is a family of clonal myeloid neoplasms, or malignancies of
the blood, caused by the failure of blood cells in the bone marrow
to develop into mature cells. Patients with MDS typically suffer
from bone marrow failure and cytopenias, or reduced counts of
platelets, red and white blood cells. The exact incidence and
prevalence of MDS are unknown because it can go undiagnosed and a
national survey canvassing both hospitals and office practitioners
has not been completed. Some estimates place MDS incidence at
15,000 to 20,000 new cases each year in the US alone with some
authors estimating incidence as high as 46,000. Literature evidence
suggests that there is a rising incidence of MDS as the age of the
population increases with the majority of patients aged above 60
years.

Median survival for patients with intermediate-2 or high-risk
disease, as defined by the International Prognostic Scoring System
(IPSS), is 4.3 to 5.6 months.1, 2 Patients with high IPSS scores
also have a high probability of experiencing transformation of
their MDS into AML, an aggressive form of blood cancer with
typically poor survival.

Over 350 patients have received sapacitabine in Phase 2 studies
in AML, MDS, CTCL and NSCLC and over 170 patients in five Phase 1
studies with both hematological malignancies and solid tumors. In
June 2009 at the Annual Meeting of the American Society of
Hematology (ASH), Cyclacel reported data from a randomized Phase 2,
single-agent study of sapacitabine including promising 1-year
survival in elderly patients with AML aged 70 years or older. In
June 2011 at the Annual Meeting of the American Society of Clinical
Oncology (ASCO), Cyclacel reported data from a pilot Phase 1/2
study including promising response rate, low 4-week and 8-week
mortality in elderly patients with AML aged 70 years or older
receiving sapacitabine alternating with decitabine. The FDA and the
European Medicines Agency have designated sapacitabine as an orphan
drug for the treatment of both AML and MDS. Sapacitabine is part of
Cyclacel's pipeline of small molecule drugs designed to target and
stop uncontrolled cell division.

At the 2010 annual meeting of the American Society of Hematology
Cyclacel reported interim data from three schedules of sapacitabine
administered as single-agent treatment over a 4-week cycle in 61
patients with IPSS intermediate-1 or higher risk MDS after
treatment failure of hypomethylating agents: 200 mg twice daily for
7 days, 300 mg twice daily for 7 days, or 400 mg twice daily for 3
days per week for 2 weeks. The primary endpoint of 1-year survival
was achieved in 29%, 30% and 35% of the patients respectively among
the 3 schedules tested. Median overall survival was 217, 232 and
236 days respectively.
Two patients achieved a CR and 13 achieved major hematologic
improvement. The mortality rate from all causes within 30 days of
randomization was 6.6%.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a biopharmaceutical company developing oral
therapies that target the various phases of cell cycle control for
the treatment of cancer and other serious diseases. Sapacitabine
oral capsules is in the SEAMLESS Phase 3 trial being conducted
under an SPA with the FDA as front-line treatment of acute myeloid
leukemia (AML) in the elderly, Phase 2 studies for AML,
myelodysplastic syndromes (MDS), solid tumors including lung
cancer, chronic lymphocytic leukemia and an investigator-led, Phase
2/3 study comparing sapacitabine to low dose cytarabine as
front-line treatment of elderly patients with AML or high risk MDS
unfit for intensive chemotherapy. Cyclacel's pipeline includes
seliciclib oral capsules in Phase 2 studies for the treatment of
lung cancer and nasopharyngeal cancer and in a Phase 1 trial in
combination with sapacitabine. Cyclacel's ALIGN Pharmaceuticals
subsidiary markets directly in the U.S. Xclair(R) Cream for
radiation dermatitis,Numoisyn(R) Liquid and Numoisyn(R) Lozenges
for xerostomia. Cyclacel's strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based
on a portfolio of commercial products and a development pipeline of
novel drug candidates. Please visit www.cyclacel.com for additional
information.

Forward-looking Statements

This news release contains certain forward-looking statements
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, the efficacy, safety and intended
utilization of Cyclacel's product candidates, the conduct and
results of future clinical trials, plans regarding regulatory
filings, future research and clinical trials and plans regarding
partnering activities. Factors that may cause actual results to
differ materially include the risk that product candidates that
appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later
clinical trials, trials may have difficulty enrolling, Cyclacel may
not obtain approval to market its product candidates, the risks
associated with reliance on outside financing to meet capital
requirements, and the risks associated with reliance on
collaborative partners for further clinical trials, development and
commercialization of product candidates. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should,"
"believes," "estimates," "projects," "potential," "expects,"
"plans,"
"anticipates," "intends," "continues," "forecast," "designed,"
"goal,"
or the negative of those words or other comparable words to be
uncertain and forward-looking. For a further list and description
of the risks and uncertainties the Company faces, please refer to
our most recent Annual Report on Form 10-K and other periodic and
other filings we file with the Securities and Exchange Commission
and are available at www.sec.gov. Such forward-looking statements
are current only as of the date they are made, and we assume no
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.

(C) Copyright 2012 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved.
The Cyclacel logo and Cyclacel(R) are trademarks of Cyclacel
Pharmaceuticals, Inc. Numoisyn(R) and Xclair(R) are trademarks of
Sinclair Pharma plc. Vidaza(R) is a registered trademark of Celgene
Corporation. Dacogen(R) is a registered trademark used by Eisai
Inc.
under license from Astex Pharmaceuticals, Inc.